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IRCT20210220050429N1 IRCT 2021-04-13 Tabriz University of Medical Sciences Effect of growth hormone in the treatment of infertility Effect of growth hormone intrauterine injection along oral hormone replacement on refractory thin endometrium in frozen embryo transfer cycles 2021-04-19 anticipated 25 Complete https://irct.ir/trial/54459 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Women infertility. Intervention group: In this prospective after-before interventional study, 25 patients aged 19-45 years with a history of endometrial thickness less than 7 mm in the estrogen therapy cycle of frozen embryo transfer are studied to evaluate the effect of intrauterine growth hormone injection on increasing endometrial thickness. These people underwent vaginal ultrasound on the second day of the menstrual cycle and if no dominant follicle is seen, the necessary treatment for endometrial preparation with oral estradiol valerate tablets, 2 mg tablets of Abu Reihan Company, Tehran, Iran, at a dose of 2 mg three times a day, It starts for 7 days, then the second ultrasound is performed and the thickness of the endometrium is measured in the longest part of the longitudinal section. If the thickness of the endometrium is less than 7 mm, the dose of the drug is 8 mg, 2 mg 4 times a day, for four days. A few days after taking a high dose of the drug, the thickness of the endometrium in the longitudinal section of the uterus is measured twice. On day 12-14 of the cycle, if the thickness of the endometrium is less than 7 mm, a slow intrauterine injection every other day, 5 units of growth hormone ,Sinatropin drug form from Sinagen Company, Basu Rat 5 ml in 1.5 cc containing 15 units of growth hormone and diluted with 0.3 ml of normal saline 0.9% percent and 0.6 cc of this solution contains 5 units of growth hormone, under the guide of abdominal ultrasound with a special catheter, Labutek-Germany, is performed until the endometrial thickness reaches or equal to 7 mm, maximum 4-5 times. If the thickness does not increase, the cycle is canceled and if the thickness increases to 7 mm and above, two days later serum estradiol level is measured. Progesterone ampoules are injected 100 mg daily for 3-5 days depending on the type of embryo transferred. Progesterone ampoules are continued for up to 12 weeks in case of pregnancy.. No - There is not a plan to make this available Justification or reason for not sharing IPD is There are no more information
public Soghra Hosseini Aghdam
Baghshomal Ave
Tabriz Iran (Islamic Republic of) 6579351386 +98 41 3553 9161 dr.s.aghdam@gmail.com Tabriz University of Medical Sciences scientific Alieh Ghasemzadeh
Baghshomal Ave
Tabriz Iran (Islamic Republic of) 6579351386 +98 41 3553 9161 alghasemzadeh@yahoo.co.uk Tabriz University of Medical Sciences Iran (Islamic Republic of) 25 infertile women aged 19-45 years with a history of endometrial thickness less than 7 mm on the last day of endometrial preparation with estrogen in the previous cycle of embryo transfer. 19 years 45 years Female Age over 45 years, Diabetic patients, History of cancer, Cardiovascular disease, Any disease that threatens the mother's life and prohibits pregnancy and fetal transfer, Uterus with adenomyosis and uterine fibroids, History of thrombosis, liver disease, Dyslipidemia N97 Women infertility Treatment - Drugs Intervention group: In this prospective after-before interventional study, 25 patients aged 19-45 years with a history of endometrial thickness less than 7 mm in the estrogen therapy cycle of frozen embryo transfer are studied to evaluate the effect of intrauterine growth hormone injection on increasing endometrial thickness. These people underwent vaginal ultrasound on the second day of the menstrual cycle and if no dominant follicle is seen, the necessary treatment for endometrial preparation with oral estradiol valerate tablets, 2 mg tablets of Abu Reihan Company, Tehran, Iran, at a dose of 2 mg three times a day, It starts for 7 days, then the second ultrasound is performed and the thickness of the endometrium is measured in the longest part of the longitudinal section. If the thickness of the endometrium is less than 7 mm, the dose of the drug is 8 mg, 2 mg 4 times a day, for four days. A few days after taking a high dose of the drug, the thickness of the endometrium in the longitudinal section of the uterus is measured twice. On day 12-14 of the cycle, if the thickness of the endometrium is less than 7 mm, a slow intrauterine injection every other day, 5 units of growth hormone ,Sinatropin drug form from Sinagen Company, Basu Rat 5 ml in 1.5 cc containing 15 units of growth hormone and diluted with 0.3 ml of normal saline 0.9% percent and 0.6 cc of this solution contains 5 units of growth hormone, under the guide of abdominal ultrasound with a special catheter, Labutek-Germany, is performed until the endometrial thickness reaches or equal to 7 mm, maximum 4-5 times. If the thickness does not increase, the cycle is canceled and if the thickness increases to 7 mm and above, two days later serum estradiol level is measured. Progesterone ampoules are injected 100 mg daily for 3-5 days depending on the type of embryo transferred. Progesterone ampoules are continued for up to 12 weeks in case of pregnancy. Chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: Check of serum BHCG. Clinical pregnancy. Timepoint: 4weeks after embryo transfer. Method of measurement: Seeing intra uterine gestational sac in vaginal sonography. Ongoing pregnancy. Timepoint: 10 weeks after embryo transfer. Method of measurement: Sonography and see the heart beat of embryo. Increase in endometrial thickness after intrauterine infusion of growth hormone. Timepoint: Measurement endometrial thickness at the beginning and at the end day of intrauterine growth hormone injection. Method of measurement: Trans sagittal vaginal sonography. Tabriz University of Medical Sciences Approved 2021-02-08 Ethics committee of Tabriz Medicine University Baghshomal Ave, Alzahra Hospital,Tabriz city, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)